The Suit Magazine

In the scientific world of pharmaceutical drug development Michael James, President and CEO of ClearView Biostructures, has been doing cutting edge work as the first and only Contract Research Organization (CRO) devoted to protein structure research in Canada.

For the past four decades, James has been deeply involved in advancing research for biotechnology and pharmaceutical companies.  James pioneered the use of X-ray crystallography in Canada. “Using X-ray crystallography we were the first lab in Canada to determine a protein crystal structure,” James told The Suit. “That led me to [thinking of] targets for drugs.” X-ray crystallography is used to identify protein and enzyme structures and their ligand binding sites. RNA viruses encode several enzymes that regulate their life cycle in the host cell.  These enzymes are targets for the design of inhibitors that will disrupt the viral life cycle; X-ray crystallographic studies provide insight on inhibitor development and improvement.

X-ray crystallography reveals exactly what happens to an enzyme over the course of the experimental drug development, so it can greatly reduce pre-clinical trials. It shows researchers which drugs are less effective, thus allowing them to be quickly eliminated from experimental trials. James explained that this process saves both time and money during pharmaceutical research and also helps to speed up the government approval process, particularly for drugs intended to treat human ailments. ClearView Biostructures is continuing to expand and develop its structure-based drug development programs.

In view of the fact that biochemistry includes dozens of diverse fields, it's impossible for a pharmaceutical company to hire specialists in every subject. CROs allow these companies to outsource highly specialized work and free up money for increased research and development. “Worldwide there are less than 50 CROs involved in protein structure research. We’re the only one in Canada. So we’re in an excellent position,” James explained.

According to the Association of Clinical Research Organizations (ACRO), CROs were predicted to reach $20 billion in revenues during 2010. CROs like ClearView Biostructures are able to expedite biochemical and pharmaceutical research by taking over highly technical projects from larger, more generalized biopharmaceutical companies. As specialists focused on doing one thing and doing it well, CROs can complete clinical drug trials an average of four to five months sooner than in-house testing and save up to $150 million during the process, according to the Independent Tufts Center for the Study of Drug Development.

James has conducted extensive work on potential drug treatments for viruses such as polio and hepatitis C. “We have worked with Viro-Chem Pharma [studying the] structure of hepatitis C polymerase and worked with them on developing potential inhibitors. They were recently bought out by Vertex Pharmaceuticals. Our work helped Viro-Chem Pharma gain credibility,” he said.

ClearView Biostructures' next priority is new and more effective drug treatments for tuberculosis. “Two billion people worldwide are affected,” James said. He is currently working on metabolic pathway enzymes to treat TB. The enzymes being studied are involved in metabolic pathways absent in humans. Thus inhibitors targeting these bacterial enzymes will have no effect on host cell metabolism. These inhibitors can be developed into new antibiotics directed specifically against tuberculosis.

James founded ClearView Biostructures 15 years ago, and he recalls the story as if it happened yesterday. “Students in our Department of Biochemistry were graduating and leaving the province,” he explained. “A partner and I wanted to provide a place to work for graduate students here in Edmonton, so we thought, ‘Let’s form a company to hire these people.’”

He offers some sage advice to new graduates: “Never lose your enthusiasm and excitement. I’ve been there [in the field of biochemistry] for 43 years,” James added, “Every new protein structure poses an interesting challenge.”

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